Holder for blood collection needle with blunting mechanism

ABSTRACT

Disclosed herein is a blood collection system comprising a blood collection tube, a tube holder, and a self-blunting blood collection needle. A blunting member is deployed upon withdrawal of a blood collection tube from the tube holder, to blunt the needle and so safeguard the patient and the technician from inadvertent needle sticks. The blunting member is retracted to re-sharpen the needle when a subsequent collection tube is inserted into the holder. The mechanism effects blunting and re-sharpening of the needle without requiring that the technician manipulate the mechanism in a manner different from that of conventional, non-blunting blood collection needles. Four types of mechanisms are disclosed: a rack and pinion mechanism; a cylindrical cam mechanism; lever mechanisms and a reversing strap mechanism.

CROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application is a continuation of U.S. application Ser. No.09/649,773, filed on Aug. 29, 2000, which is a continuation-in-part ofU.S. application Ser. No. 09/199,742, filed on Nov. 25, 1998, now U.S.Pat. No. 6,146,337, which claims the benefit of U.S. ProvisionalApplication No. 60/211,897, filed Jun. 16, 2000, the disclosures all ofwhich are incorporated by reference.

BACKGROUND OF THE INVENTION FIELD OF THE INVENTION

[0002] The present invention pertains to self-blunting needle devicesand, in particular, to holders for blood collection needles.

[0003] Conventional blood collection systems are known in the art tocomprise a holder, typically in the form of a generally cylindricalshell that holds a double-ended needle cannula. One end of the needlecannula extends forward from the holder and is used for venipuncture(the “venipuncture needle”), while the other end (the “filling needle”)extends into the holder and is used to puncture the seal cap on a samplefluid collection tube (which, typically, is vacuum sealed). The deviceis used by unsheathing the venipuncture needle and effectingvenipuncture and then inserting the sealed end of a collection tube intothe holder and pushing the seal cap against the boot that covers the tipof the filling needle. The filling needle pierces the boot and the sealcap and blood is drawn into the collection tube. If additional samplesare required, the first collection tube is removed and a secondcollection tube is pushed into the holder in its place. When the lasttube is filled, the blood collection needle is withdrawn from thepatient's vein.

[0004] Prior art self-blunting blood collection needles have provided adeployable, locking, blunting member to protect the user againstinadvertent needle sticks but required the user to engage in anextraneous manipulation of the sample tube in order to deploy theblunting member such as the insertion of the sample tube past adiscernible “stop” point at which the collection tube is already fullyengaged by the filling needle. There is need, therefore, for a selfblunting needle mechanism that does not require manipulation beyond thatwhich is familiar to medical technicians with the use of conventionalblood collection needles.

SUMMARY OF THE INVENTION

[0005] The present invention relates to a needle holder apparatuscomprising a shell dimensioned and configured for receiving and holdinga sample collection tube therein and for carrying thereon a needlecannula, an actuator movably disposed in the shell for engaging andmoving a blunting member longitudinally within the shell and means formoving the actuator between a forward position and a retracted positionin response to the insertion and withdrawal of a sample collection tubein the shell.

[0006] According to one aspect of the invention, the means for movingthe actuator may comprise a transmitter device connected to the shelland being configured to move obliquely in the shell upon insertion ofsuch sample collection tube into the shell. There may also be a linkagebetween the transmitter device and the actuator to convert the obliquemotion of the transmitter device into rearward motion of the actuatorwhen such sample tube is inserted into the apparatus. The apparatus mayinclude a biasing member positioned and configured to urge the actuatortoward the forward position.

[0007] In one species of the invention, the linkage may comprise a camand follower engagement between the actuator and the transmitter device.Optionally, there may be a staggered cam and follower engagement betweenthe actuator and the transmitter device.

[0008] According to yet another aspect of the invention, the transmitterdevice may be configured to contact such sample collection tube at apoint between the connection to the shell and the linkage to theactuator.

[0009] According to yet another aspect of the invention, the transmitterdevice may extend forwardly in the shell from its point of attachment tothe shell.

[0010] According to still another embodiment of the invention, thetransmitter device may comprise at least two transmitter arms.

[0011] According to another aspect of the invention, either of theactuator and the transmitter device may comprise a cam surface.

[0012] The apparatus may comprise a biasing member urging the actuatormember toward the forward position.

[0013] In a particular embodiment, this invention may provide a needleholder apparatus comprising a shell dimensioned and configured forreceiving and holding a sample collection tube therein and for carryingthereon a needle cannula, an actuator movably disposed in the shell forengaging and moving a blunting member axially within the shell, atransmitter device connected to the shell and being configured tocontact a sample collection tube which may be inserted into the shelland to move obliquely relative to the motion of the sample collectiontube, and a positive motion cam engagement between the transmitterdevice and the actuator to convert the oblique motion of the transmitterdevice into axial motion of the actuator, to move the actuator axiallyin the shell in response to the oblique motion of the transmitterdevice, wherein the apparatus is biased to dispose the actuator in theforward position.

[0014] The present invention also provides a blood collection needlecomprising a shell dimensioned and configured for receiving and holdinga sample collection tube therein, a needle cannula carried on the shell,a blunting member disposed telescopically within the needle cannula formovement between a withdrawn position which disposes the needle in asharpened configuration and a blunting position which disposes theneedle in a blunted configuration, and a mechanism for moving theblunting member to the withdrawn position when a sample collection tubeis inserted into the holder and for moving the blunting member to theblunting position when the sample collection tube is withdrawn from theshell.

[0015] In a particular embodiment, the mechanism may comprise anactuator movably disposed in the shell, the actuator being secured tothe blunting member so that the blunting member can be moved between theblunting position and the withdrawn position by movement of theactuator, a movable transmitter device connected to the shell and beingconfigured for contact with a sample collection tube which may beinserted into the shell and to move obliquely relative to the motion ofa sample collection tube in the shell, a biasing member configured tourge the blunting member to the blunting position upon withdrawal of asample collection tube from the shell, and a linkage between thetransmitter device and the actuator to convert the oblique motion of thetransmitter device into forward and rearward motion of the actuator, tomove the blunting member from the blunting position to the withdrawnposition.

[0016] Further details concerning the invention are described below withreference to the appended Figures.

BRIEF DESCRIPTION OF THE DRAWINGS

[0017]FIG. 1A is a cross-sectional view of a needle hub for holding aneedle cannula in a blood collection device;

[0018]FIG. 1B is a perspective view of a blunting member shuttleintended for use with the needle hub of FIG. 1A;

[0019]FIG. 1C is a view of the shuttle of FIG. 1B taken along line1C-1C;

[0020]FIG. 1D is a cross-sectional view of a safety needle assemblycomprising the hub and shuttle of FIGS. 1A and 1B with a needle cannulaand blunting cannula secured therein;

[0021]FIG. 2 is a cross-sectional view of a collection tube holder and ablunting mechanism for use with the present invention;

[0022]FIG. 3 is a cross-sectional view of a passive blood collectionneedle in accordance with a particular embodiment of the presentinvention, comprising the holder and blunting mechanism of FIG. 2 andthe needle assembly of FIG. 1D;

[0023]FIGS. 4A and 4B are views similar to FIG. 3 of the device of FIG.3 in the insertion and blunted configurations, respectively;

[0024]FIG. 5A is a schematic plan view of a rotator element for use in ablunting mechanism in accordance with another embodiment of the presentinvention;

[0025]FIG. 5B is a cross-sectional view of the element of FIG. 5A takenalong line 5B-5B;

[0026]FIG. 5C is a cross-sectional view of the element of FIG. 5A takenalong line 5C-5C;

[0027]FIG. 6 is an exploded perspective view of a transmitter elementand an actuator element for use with the rotator element of FIG. 5A in ablunting mechanism in accordance with the present invention;

[0028]FIG. 7A is a perspective view of a sample tube holder for use withthe elements shown in FIGS. 5A and 6;

[0029]FIG. 7B is a view of the holder of FIG. 7A taken along line 7B-7B;

[0030]FIGS. 8A and 8B are schematic cross-sectional views of a passiveblood collection needle comprising the elements shown in FIGS. 5A, 6 and7A, in the blunted and insertion configurations, respectively, with theneedle assembly omitted to clarify the drawing;

[0031]FIG. 8C is a view similar to FIGS. 8A and 8B of the bluntingmechanism as it will be configured upon the initial installation of alocked needle assembly prior to insertion of a sample collection tube;

[0032]FIG. 8D is an elevation view of a transmitter device of a bluntingmechanism according to yet another embodiment of this invention;

[0033]FIG. 8E is an elevation view of the transmitter device of FIG. 8Dtogether with a blood collection tube in a holder shell shown in crosssection;

[0034]FIG. 9A is a cross-sectional schematic view of a bluntingmechanism in a needle holder in accordance with a first lever embodimentof the present invention;

[0035]FIG. 9B is a plan view of ring lever 210 of FIG. 9A;

[0036]FIG. 9C is a perspective view of the ring lever 210 of FIG. 9B;

[0037]FIG. 9D is a perspective view of an alternative embodiment of alever-type mechanism similar to the one of FIGS. 9A-9C;

[0038]FIGS. 10A and 10B are schematic cross-sectional views of a bloodcollection needle in accordance with still another embodiment of thepresent invention;

[0039]FIG. 11 is a schematic cross-sectional view of a blood collectionneedle comprising a needle holder in accordance with another leverembodiment of the present invention;

[0040]FIGS. 12A and 12B are cross-sectional views of a holder for ablood collection needle in accordance with another embodiment of theinvention;

[0041]FIG. 12C is an end view of the embodiment of FIGS. 12A and 12B;

[0042]FIG. 13A is a cross-sectional view of a holder according to yetanother embodiment of the invention;

[0043]FIG. 13B is a partial perspective view of an arm extension andactuator of FIG. 13A shown in an initial, blunted configuration withouta sample tube in the device;

[0044]FIG. 13C is a view of the structures of FIG. 13B locked in ablunted position after the withdrawal of a sample tube from the device;

[0045]FIG. 14A is a schematic view of a needle holder in accordance withstill another embodiment of the invention;

[0046]FIG. 14B is a view of the holder of FIG. 14A taken generally alongthe line indicated at B-B in FIG. 14A;

[0047]FIG. 14C is a perspective view of the transmitter arms andactuator of the mechanism shown in FIG. 14A; and

[0048]FIG. 15 is a schematic view of the holder of FIG. 14A with aneedle, blunting member and sample collection tube therein, and with thedevice in the sharpened configuration.

DETAILED DESCRIPTION OF THE INVENTION AND PREFERRED EMBODIMENTS THEREOF

[0049] The present invention relates to a holder for a blood collectionneedle having a movable blunting member. The holder has a mechanism forengaging and deploying a blunting member upon withdrawal of a bloodcollection tube from the tube holder, to blunt the venipuncture needleand so safeguard the patient and the technician from inadvertent needlesticks. The mechanism may function to retract the blunting member tore-sharpen the venipuncture needle when a subsequent collection tube isinserted into the holder. The mechanism is responsive to the insertionand withdrawal of the blood collection tube to retract and deploy theblunting member accordingly. One basic and novel feature of the presentinvention is that the mechanism allows the user to blunt and,optionally, re-sharpen the venipuncture needle without requiringmanipulation of the collection tube or the needle holder other than thatnormally performed for conventional blood collection needle systems, asdescribed above. For example, it is not necessary to manipulate theblunting member in any manner other than by the insertion or withdrawalof the sample tube to engage or disengage the filling needle. Four typesof mechanisms are disclosed: a rack and pinion mechanism, a cylindricalcam mechanism, a lever mechanism, and a pliable, resilient strapmechanism. Generally, the mechanism in each of these devices comprisesan actuator member which engages the blunting member for movement in theholder between a forward or deployed position which places the device ina blunted configuration and a rearward or withdrawn position whichplaces the device in a sharpened configuration. The mechanism alsocomprises a transmitter which is moved by a sample collection tube asthe tube is inserted into or removed from the device. The mechanism isdesigned to convert motion imposed on the transmitter device uponinsertion of a sample collection tube as it is inserted into the deviceinto a rearward motion of the actuator and consequently into withdrawalof a blunting member, if one is secured to the actuator.

[0050] In some embodiments the transmitter moves forward or rearward inthe device with the sample collection tube and the mechanism includes areversing member for imparting a motion on the actuator in a directionopposite to that of the transmitter device. In other embodiments, themechanism includes a cam and follower engagement between the transmitterand the actuator. In another embodiment, the transmitter moversobliquely relative to the sample collection tube.

[0051] Also disclosed is an optional safety needle assembly comprising aneedle cannula mounted in a needle hub combined with a blunting membermounted in a shuttle. The blunting member is designed to be receivedwithin the needle cannula and the shuttle is configured to be receivedwithin the needle hub. A locking mechanism comprising a detentresiliently mounted on the shuttle is configured to releasably engagelocking apertures in the needle hub. The locking mechanism and theblunting mechanism may be used together by configuring the bluntingmechanisms to release the detent from the locking apertures when theneedle assembly is installed in the needle holder.

[0052]FIG. 1A shows a needle hub 10 that comprises a generallycylindrical body 12 having a longitudinal axis A, a first end 12 a and asecond end 12 b. Needle hub 10 also comprises a circumferential lockingflange 18 and at least one locking spline 20 (FIG. 1D) by which needlehub 10 can be secured in a needle holder, as described below. Theinterior of needle hub 10 comprises a hub passageway 14 extendingtherethrough. The shuttle portion 14 b of passageway 14 (generallybetween second end 12 b and flange 18) is dimensioned and configured toslidably receive a shuttle (FIG. 1B) therein. Body 12 defines twolocking notches 16 a and 16 b and a channel 16 c formed together as anaperture through the cylindrical wall of body 12. The mounting portion14 a of passageway 14 (generally between flange 18 and first end 12 a)is dimensioned and configured to receive a needle cannula in the forwardend thereof. The funnel-like insertion regions 14 c and 14 d at the endsof mounting portion 14 a of passageway 14 converge from the shuttleportion 14 b and the first end of hub 10, respectively, and facilitatethe insertion therein of a blunting member and a needle cannula inassembly steps described below.

[0053]FIG. 1B shows a blunting member shuttle 24 which has a generallycylindrical body that is dimensioned and configured to be slidablyreceived within the shuttle portion 14 b of passageway 14 of hub 10, aswill be described below. Shuttle 24 defines a central axial passageway24 a therethrough within which may be mounted a blunting member. Shuttle24 comprises a detent 28 that is mounted on the end of a resilient arm24 b. Resilient arm 24 b suspends detent 28 at a stand-off from theremainder of the shuttle body, indicated as stand-off S in the end viewof FIG. 1C. As is evident from FIG. 1C, detent 28 has a protrudingsurface 28 a that is disposed obliquely relative to the cylindricalperiphery of shuttle 24. Therefore, a force applied upon surface 28 asubstantially along a tangent to the shuttle body (or parallel to such atangent) can drive detent 28 in a radial direction (towards passageway24 a), narrowing stand-off S by flexing arm 24 b.

[0054] Shuttle 24 comprises shuttle flanges 32 that permit shuttle 24 toengage another structure, as described below. Shuttle 24 also defines aboot barb 34 on which a self-sealing boot for sealing the sharpenedinsertion end 26 b of blunting member cannula 26 may be anchored, as iswell-known in the art.

[0055]FIG. 1D shows a safety needle assembly 30 that comprises needlehub 10, a hollow needle cannula 22 mounted therein, shuttle 24 and ahollow second cannula 26 mounted therein. Needle cannula 22 has a bluntproximal end that is inserted into the first end 12 a of hub 10 and issecured therein by means of adhesive (not shown). The distal end ofneedle cannula 22 comprises a puncture tip. Passageway 14 defines aproximal insertion region 14 d that converges rearward from first end 12a and thus facilitates the insertion of the blunt end of needle cannula22 into passageway 14. The shuttle portion 14 b of passageway 14 isdimensioned and configured to slidably receive shuttle 24 therein. Aportion of second cannula 26 extends forward from shuttle 24 throughpassageway 14 and into needle cannula 22, within which it istelescopically disposed and wherein it terminates at a first, blunt end.The forward extending portion of second cannula 26 is referred to hereinas the blunting member 26 a. Second cannula 26 and needle cannula 22cooperate to form a fluid flow passageway that extends through both ofthem. Thus, the blunting member 26 a and the needle cannula 22 aredisposed telescopically one within the other without obstructing flowthrough the needle passageway. Preferably, insertion region 14 cconverges to a diameter that is smaller than the internal diameter ofneedle cannula 22 and it is aligned therewith so that it provides a stopfor the insertion of needle cannula 22 into body 12 as well as guidingblunting member 26 a of blunting member cannula 26 into the proximal endof needle cannula 22. Second cannula 26 also extends rearward fromshuttle 24, terminating at a second, sharp end (sometimes referred toherein as a “filling needle”) for puncturing the seal on a collectiontube and for providing a conduit to establish fluid flow communicationbetween the collection tube and needle cannula 22, as will be describedbelow. Second cannula 26 is securely mounted within shuttle 24 so thatit moves with shuttle 24.

[0056] Detent 28 on shuttle 24 is dimensioned and configured to protrudethrough, and to be secured within, locking notches 16 b and 16 a, tosecure the relative positions of shuttle 24 and needle hub 10. FIG. 1Dshows needle assembly 30 in an insertion configuration (sometimesreferred to herein as the “sharp configuration”), in which shuttle 24 isin a retracted position in hub 10. As shown, assembly 30 is locked inthe sharp configuration by the engagement of detent 28 in rear lockingnotch 16 b. Pressing detent 28 into passageway 14 disengages the detentfrom notch 16 b so that shuttle 24 may be advanced within passageway 14.Detent 28 can slide along channel 16 c until it engages forward lockingnotch 16 a, thus securing shuttle 24 in an advanced or extended positionwithin needle hub 10, resulting in a blunted configuration in which theblunt end of blunting member 26 a protrudes beyond the sharp tip ofneedle cannula 22 (as indicated in dotted outline), blunting the needleassembly.

[0057] One embodiment of a needle assembly holder in accordance with thepresent invention is shown in FIG. 2. Holder 36 comprises a cylindricalshell 38 that defines a needle aperture 40 at its forward end. Aperture40 is dimensioned and configured to receive a needle assembly comprisinga needle cannula and a blunting member that are telescopically andmovably disposed one within the other, such as needle assembly 30 (FIG.1D). An annular flange 40 a protrudes into aperture 40 and definesnotches (not shown) that are sized to allow spline 20 and detent 28 topass therethrough as needle hub 10 is inserted into aperture 40. Flange40 a, however, is dimensioned and configured to engage hub flange 18 ofneedle assembly 30 (FIG. 1D). Flange 40 a may be configured to bereceived in a friction fit between flanges 18 and spline 20 (FIG. 1D)when hub 10 is inserted into aperture 40 as far as flanges 18 and 40 awill permit and then rotated to move spline 20 out of alignment with thenotch in flange 40 a. A stop lug (not shown) is positioned in aperture40 to engage spline 20 upon such rotation and thus limit the rotation toa suitable turn, e.g., 45 degrees. Needle assembly 30 may thus bemounted in holder shell 38.

[0058] Shell 38 contains a mechanism 42. Mechanism 42 comprises atransmitting sleeve 44 comprising racks 46 which, in the illustratedembodiment, comprise toothed splines. Mechanism 42 further comprisespinions 48 which, in the illustrated embodiment, comprise toothed gears,and an actuator ferrule 50 comprising racks 52. Mechanism 42 alsoincludes a spring 54. Pinions 48 engage racks 46 and 52 and thus serveas a link between them. In this embodiment and in the others describedherein, the link member and its manner of connection to the transmitter,to the shell and to the actuator serve as means for moving the actuatorin the holder in an opposite direction from that of the transmitter.Transmitting sleeve 44 is slidably disposed in the interior of shell 38and racks 46, which are preferably diametrically opposed from oneanother in shell 38, are slidably disposed in axial grooves in theinterior wall of shell 38. Transmitting sleeve 44 has at its couplingend 44 a an access aperture 44 b. Coupling end 44 a is dimensioned andconfigured to engage the filling end of a conventional collection tubeand aperture 44 b permits the sharp end of a filling needle such as theend of cannula 26 (FIG. 1D) to protrude therethrough into a collectiontube. Pinions 48 are mounted in shell 38 and are dimensioned andconfigured to rotatably engage racks 46 of transmitting sleeve 44. FIG.2 shows mechanism 42 in a deployed configuration, i.e., a configurationin which actuator ferrule 50 is positioned forward in shell 38, where itcan be retracted or withdrawn (moved downward, as sensed in the Figure),as will be described herein. (This position is referred to as“deployed”. When the actuator ferrule engages a blunting member in thisposition, the blunting member is extended, to blunt the needle, as willbe described herein.) Spring 54, between end cap 50 a of actuatorferrule 50 and transmitting sleeve 44, is lightly compressed to bias themechanism into the illustrated pre-filling position and is situated sothat it is tensioned against the transmitting sleeve 44 whentransmitting sleeve 44 and actuator ferrule 50 approach each other asdescribed below. Actuator ferrule 50 is disposed within shell 38 andcomprises a pair of racks 52 that engage pinions 48. The interior offerrule 50 is dimensioned and configured to permit the insertion androtation of needle assembly 30 therein as is necessary to mount needleassembly 30 in shell 38, without depressing detent 28 (FIG. 1D). Forexample, ferrule 50 may have an L-shaped groove on its interior surface,with detent 28 moving in an axial or longitudinal leg of the groove asneedle assembly 30 is inserted into shell 38. Detent 28 may then move ina circumferential leg of the groove when needle assembly 30 is rotatedin aperture 40. Alternatively, ferrule 50 may have an internal lug orfillet positioned to engage detent 28 only after needle assembly 30 ismounted in shell 38 and ferrule 50 is moved rearward.

[0059] Analogously to the interrelation on needle assembly 30 (FIG. 1D)of spline 20 and annular flange 40 a, the shuttle flanges 32 on shuttle24 are eccentrically configured about the longitudinal axis of thedevice, and actuator ferrule 50 forms a cap aperture in cap 50 a that isconfigured to align with flanges 32 and permit them to pass therethroughupon initial insertion of needle assembly 30 into shell 38. Spring 54 isconfigured so that, when the shuttle flanges 32 pass through theaperture in cap 50 a, they engage spring 54. The rotation of needleassembly 30 that mounts the assembly in shell 38 also turns flanges 32out of alignment with the aperture so that cap 50 a can thereafterengage the flanges 32 under the force of spring 54. Actuator ferrule 50can thus engage blunting member 26 a, via shuttle 24.

[0060] Mechanism 42 is dimensioned and configured so when transmittingsleeve 44 is moved forward within shell 38 (e.g., as a result of theinsertion of a collection tube), actuator ferrule 50 moves in thereverse direction, away from forward end 36 a, under the operation ofpinions 48. Mechanism 42 thus moves from the pre-filling configurationshown in FIG. 3 to a filling configuration. Such movement also imposesfurther tension or compressive force on spring 54.

[0061] The fully assembled blood collection needle 55 is shown in FIG. 3with needle assembly 30 mounted in aperture 40 (FIG. 2). The needlecannula 22 is in fixed relation to the holder because of the engagementof annular flange 40 a (FIG. 2) with flange 18 (FIG. 1D) and spline 20(FIG. 1D, not seen in FIG. 3). Collection needle 55 is in an initial,pre-filling configuration in which needle assembly 30 is in a sharpenedconfiguration even though actuator ferrule 50 is in a deployed position,because shuttle 24 on blunting member 26 a has not yet engaged actuatorferrule 50. Note that shuttle flanges 32 of needle assembly 30 protrudebeyond end cap 50 a (FIG. 2) of ferrule 50 and compress spring 54.Shuttle 24 resists being moved by spring 54 forward into hub 10 becausedetent 28 is locked in notch 16 b (FIG. 1A), leaving needle assembly 30locked in the sharp configuration, ready for venipuncture.

[0062] To prepare blood collection needle 55 for use, a technician willtypically install needle assembly 30 in holder 36 as shown in FIG. 3,and then remove from needle cannula 22 a protective sheath (not shown)and insert needle cannula 22 into a patient's vein. Then, the technicianwill take a conventional collection tube 56 a (FIG. 4A) and insert thecapped end thereof into the open end 38 a of shell 38 with sufficientforce to assure that filling needle 26 b punctures the seal cap 56 b onthe collection tube, thus establishing flow communication between thecollection tube and the needle assembly. This action will imposesufficient force on coupling end 44 a to drive transmitting sleeve 44forward in needle holder 36 (upward as sensed in FIG. 3) and willcompress spring 54. The operation of mechanism 42 will transfer theforward motion of transmitting sleeve 44 into rearward movement ofactuator ferrule 50 indicated by arrows 56 (downward, as sensed in FIG.3), under the operation of pinions 48. Thus, mechanism 42 causesactuator ferrule 50 to move in a direction opposite from that oftransmitting sleeve 44. The interior of ferrule 50 is configured so thatsuch rearward movement causes it to depress detent 28 and thus unlockthe needle assembly. Shuttle flanges 32 then bear on end cap 50 a underthe force of spring 54. This motion will conclude with mechanism 42 inthe retracted configuration shown in FIG. 4A, in which actuator ferrule50 and shuttle 24 are in their retracted positions due to theadvancement of transmitting sleeve 44, leaving needle assembly 30 in thesharpened configuration. With the forward end of needle cannula 22 in apatient's vein and the filling needle 26 b of second cannula 26 in anevacuated collection tube, blood will flow through the fluid flowpassageway of the device to fill the collection tube. It is advantageousfor the needle assembly 30 to be sharp while the sample tube is fillingbecause the filling process may be interrupted if the needle is jostledor obstructed and it may be necessary for the technician to re-positionthe needle in the vein; this is better accomplished with a sharp needlethan a blunt one. Upon subsequent withdrawal of the collection tube 56 afrom shell 38, transmitting sleeve 44 will move according to the bias ofspring 54 in the direction of arrows 58. The operation of the mechanism42 will, accordingly, move actuator ferrule 50 in the oppositedirection, towards its forward (upward), pre-filling position. Shuttle24 will also move forward (upward, as sensed in the Figure) with ferrule50, under the impetus of spring 54, so that the blunt end of theblunting member 26 a is extended beyond the tip of needle cannula 22,thus blunting the device. Shuttle 24 locks in the forward position withthe blunting member 26 a extending beyond the puncture tip of needlecannula 22 before actuator ferrule 50 stops its forward movement. Theadditional forward movement of actuator ferrule 50 relative to shuttle24 allows the internal fillet or groove that previously unlocked theneedle assembly to disengage from the locking detent. Accordingly,detent 28 can engage locking notch 16 a to lock needle assembly 30 inthe blunted configuration. The additional forward movement of ferrule 50also causes end cap 50 a to disengage from shuttle flanges 32. Mechanism42 comes to rest in the deployed configuration shown in FIG. 4B.Subsequent insertion of another collection tube will cause the actuatorferrule 50 to move rearward again, unlocking shuttle 24 and thenengaging shuttle flanges 32 to return to the sharpened configurationshown in FIG. 4A, and removal of the tube thereafter will once againreturn the device to the blunted configuration of FIG. 4B. Thus, afterthe initial insertion of a sample tube, mechanism 42 serves to moveactuator ferrule 50 and the blunting member 26 a in a direction contraryto that of the sample tube and transmitting sleeve 44 in the holdershell. Such motion is illustrated as changes between the configurationsof FIGS. 4A and 4B.

[0063] In an alternative embodiment, actuator ferrule 50 may carrylocking flanges disposed about the central aperture of end cap 50 a(FIG. 2). Such locking flanges may be configured to engage shuttleflanges 32 (FIG. 1D) when the first insertion of a blood collection tubemoves actuator ferrule 50 rearward from the initial configuration (FIG.3) to the filling configuration shown in FIG. 4A.

[0064] In an alternative aspect of this invention, a mechanism inaccordance with the present invention may incorporate a cam and followerarrangement instead of a rack and pinion arrangement. In such anembodiment, a rotating cylindrical cam (referred to herein as a“rotator”) will be disposed within the cylindrical body of the needleholder carrying the self-blunting needle assembly. An actuator structure(or “inner sleeve”) that engages the blunting member will follow the camsurface of the rotator. When the rotator rotates within the needleholder, the actuator follows by imposing a corresponding axial motion onthe blunting member in accordance with the direction of rotation of therotator. The device is configured so that the forward insertion of asample tube into the needle holder rotates the rotator in a directionthat causes the actuator to retract (rearward) within the needle holder.The rotating cam embodiment of the present invention, like the rack andpinion embodiment, creates contrary motion between the blunting memberand the sample tube inserted into the holder with each insertion andwithdrawal of a tube, except for the first time a collection tube isinserted into the holder. Such a device can employ the safety needleassembly 30 of FIG. 1B, as described below.

[0065]FIGS. 5A, 5B and 5C provide related views of a cylindrical cam or“rotator” 100 for use in one embodiment of the present invention. In theplan view of FIG. 5A, rotator 100 is seen to have a round periphery,thus allowing for coaxial rotation within a cylindrical needle holder.Rotator 100 has three principal concentric annular segments: at leastone following surface 102, at least one driving surface 104 and acentral collet 106. Following surfaces 102 are disposed in thecircumferential, outermost annular segment of rotator 100, whichincludes a flat upper surface 102 a and a flat lower surface 102 b.Driving surfaces 104 are concentrically contiguous with followingsurfaces 102. Proceeding radially inward, the next annular segment ofrotator 100 is collet 106, which is physically connected to surfaces 102and 104 by a bridge 108. Bridge 108 spans a region between collet 106and driving surfaces 104 that is occupied principally by a curvate gap110. The interior region 112 of collet 106 defines a recess 114 withinwhich is disposed an unlocking fillet 114 a. Fillet 114 a is betterviewed in FIG. 5B, which also shows that the following surfaces 102occupy a first annular region R1 and driving surfaces 104 occupy thecontiguous annular region R2.

[0066] As is evident from FIG. 5C, rotator 100 can be disposed withinthe generally cylindrical shell 138 of a needle holder, rotatablyresting on the bottom shoulder 138 a of shell 138. So disposed, theimpingement of an axial force as indicated, e.g., by arrow 152 a, onfollowing surface 102 will cause rotator 100 to rotate in the directionof arrow 152 b. If the structure imposing the force at arrow 152 a isnot permitted rotational movement as it bears on surface 102, it willmove downward (axially) as rotator 100 rotates. Since driving surfaces104 slope in a helical direction opposite from that of followingsurfaces 102, a structure that is slidably disposed on surface 104 andthat is constrained against rotation will move upward on the contraryincline of driving surface 104 as the structure on surface 102 movesdownward, as will be discussed further below.

[0067] A force transmitter and cam follower/actuator that bear onsurfaces 102 and 104, for driving and following rotator 100, are shownin an exploded coaxial relationship in FIG. 6. Transmitter 120 has agenerally cylindrical configuration dimensioned to have the same outerdiameter as rotator 100 so that the two can fit snugly in the samecylindrical needle holder shell. However, transmitter 120 also comprisesguiding means for engaging the interior surface of the shell so thattransmitter 120 will be inhibited against free rotational motion withinthe shell. Preferably, it will be constrained for axial motion withinthe shell. In the embodiment of FIG. 6, the guiding means of transmitter120 comprises a pair of peripheral guiding fillets 122 that aredimensioned and configured to be slidably received withinaxially-extending grooves in the interior wall of the shell within whichtransmitter 120 is disposed. With the fillets 122 disposed in suchgrooves, transmitter 120 will be able to move axially, i.e.,longitudinally, within the holder shell, but will not be able to rotatetherein. Transmitter 120 comprises a pair of driving surfaces 124 thatare dimensioned and configured to engage following surfaces 102 ofrotator 100 in annular region R1, within which they define a cylindricalreceiving region C.

[0068] Also shown in FIG. 6 is actuator 130 which has a cylindricalouter configuration having a diameter D dimensioned to be receivedwithin receiving region C of transmitter 120. Actuator 130 has a centralaperture 132 into which locking tabs 134 a, 134 b extend, for engagingthe shuttle flanges 32 of needle assembly 30 (FIG. 1B). Actuator 130defines a pair of following surfaces 136 that are dimensioned andconfigured for complementary engagement with driving surfaces 104 inannular region R2 of rotator 100. However, actuator 130 is constrainedagainst rotational movement by the engagement of internal lugs 139 witha pair of posts (not shown) that extend upward from bottom shoulder 138a of shell 138 and which protrude through rotator 100 via gap 110.

[0069]FIG. 7A provides a perspective view of a sample tube holder thatmay house a mechanism comprising the rotator 100, transmitter 120 andactuator 130 of FIGS. 5A, 5B, 5C and FIG. 6. The holder comprises ashell 138 having a longitudinal axis A and a shoulder 138 a at itsforward end. Shell 138 defines a pair of internally, axially disposedgrooves 122 a, shown in dotted outline. FIG. 7B provides an end view ofshell 138, showing aperture 138 b which is dimensioned and configured toreceive safety needle assembly 30 of FIG. 1D. Aperture 138 b issubstantially circumscribed by a flange 138 c that is dimensioned andconfigured to permit the blunting component and rearward portion of theneedle hub therein, but to engage hub flanges 18 (FIG. 1D), leaving thefirst end 12 a of needle hub 12 extending forward from shoulder 138 a.Notch 138 e is configured to receive a locking spline 20 (FIG. 1D), andnotch 138 f is dimensioned and configured to allow the detent 28 (FIGS.1C and 1D) to pass through aperture 138 b to avoid unlocking the needleassembly as it is first being inserted into shell 138. After insertionof the needle assembly into the aperture, the needle assembly is rotatedso that the locking spline and flanges 18 engage flange 138 c. Also seenin FIG. 7B are two posts 138 g that extend axially from shoulder 138 atowards the rearward end of shell 138.

[0070]FIGS. 8A and 8B are cross-sectional schematic drawings thatindicate the relative positions of the transmitter 120, rotator 100 andactuator 130 in two different configurations within shell 138. FIG. 8Adepicts the holder mechanism in the deployed configuration. In thisconfiguration, rotator 100 is rotatably situated within shell 138 and,because it is resting on shoulder 138 a, it is constrained againstforward axial movement. The transmitter 120 is disposed in shell 138 sothat the lower (as sensed in FIG. 8A) portions of its helical drivingsurfaces 124 engage the upper portions of the following surfaces 102 ofrotator 100. Transmitter 120 carries fillets 122 that engage grooves 122a in shell 138 and thus permit axial sliding motion of transmitter 120in shell 138 but prevent rotational motion. Actuator 130 is disposedwithin the outermost annular region of rotator 100, with followingsurfaces 136 engaging driving surfaces 104. An internal post 138 gextending from shell 138 through gap 110 (FIG. 5B) engages lug 139 toprevent actuator 130 from rotating within shell 138. A spring 154 isdisposed axially between transmitter 120 and actuator 130.

[0071] When a forward (downward, as sensed in the Figure) force isimposed on bearing surface 120 a of transmitter 120, e.g., by pressing asample collection tube into shell 138, transmitter 120 moves downward,as indicated by arrow 156 a and the spiraled driving surface 124 bearsupon the complementary following surface 102 of rotator 100. Sincetransmitter 120 is con-strained against rotation, transmitter 120 actsas a driving cam follower and the downward motion of transmitter 120causes rotator 100 to rotate within shell 138. Such rotation of rotator100 will cause driving surface 104 to impose a force upon followingsurface 136 of actuator 130. Since actuator 130 is constrained againstrotational motion by the engagement of lugs 139 with the posts 138 gextending upward from shoulder 138 a, the force imposed by drivingsurface 104 will cause actuator 130 to move upwards (as indicated byarrow 156 b). Thus, rotator 100 serves as a linking member that movesactuator 130 in a direction opposite from that of transmitter 120. Theresult of the downward axial motion of transmitter 120 is the retractedconfiguration depicted in FIG. 8B, which shows rotator 100 in a rotatedposition and actuator 130 in an elevated position relative to FIG. 8A.

[0072] As transmitter 120 and actuator 130 move towards each other fromthe pre-filling configuration of FIG. 8A to the filling configuration ofFIG. 8B, they compress spring 154. The friction fit of a collection tubein shell 138 is sufficient to withstand the tendency of spring 154 todecompress and move transmitter 120 (and the collection tube pressingagainst it) upward. However, upon manual removal of the collection tube,spring 154 will drive transmitter 120 upward so that it remains incontact with the collection tube until it encounters a stop lug on theinterior wall of shell 138, e.g., lug 122 b in groove 122 a. During thewithdrawal process, the upward motion of transmitter 120 will tend todisengage driving surface 124 from following surface 120. However, theresidual downward force imposed by spring 154 on actuator 130 will causefollowing surface 136 to bear on driving surface 104, to which rotator100 will respond by rotating sleeve 138 until following surface 102again engages driving surface 124. Further withdrawal of the collectiontube will allow spring 154 to drive transmitter 120 still higher andactuator 130 still lower in shell 138, thus imposing further rotation onrotator 100 until the configuration of FIG. 8A is regained.

[0073] As with the rack and pinion embodiment of FIGS. 1 through 4B, theneedle assembly 30 is first inserted into the shell 138 in the sharpenedconfiguration (shown in FIG. 1D) with mechanism 142 in the deployedconfiguration of FIG. 8A. As needle assembly 30 is inserted intoaperture 138 b, detent 28 (FIG. 1D) passes through notch 138 f (FIG. 7B)of shell 138, and then alongside fillet 114 a (FIG. 5B). Locking spline20 (FIG. 1D) passes through notch 138 e (FIG. 7B), and hub flanges 18(FIG. 1D) come to a stop against flange 138 c (FIGS. 7B, 8A). The needleassembly is rotated to engage flange 138 c between spline 20 and flanges18, thus locking the needle in the holder. This rotation disposes detent28 beside fillet 114 a. Meanwhile, the shuttle flanges 32 bear againstlocking tabs 134 a of actuator 130, pushing actuator 130 upward (assensed in FIG. 8A) and lifting it off rotator 100 to the position shownin FIG. 8C. The rotation of needle assembly 30 that engages flange 138 calso positions shuttle flanges 32 (FIG. 1B, 1D) between locking tabs 134a and 134 b. Transmitter 120 and rotator 100 are in a deployedconfiguration, but actuator 130 is retracted and the needle assembly issharp.

[0074] When the first sample tube is inserted into holder shell 138, itbears on transmitter 120, which moves downward, causing rotator 100 torotate. This makes fillet 114 a swipe surface 28 a (FIG. 1C) on detent28 and unlock the needle assembly. Shuttle 24 then allows actuator 130to move forward (downward as sensed in FIG. 8A), but only until itsfollowing surface 136 engages driving surface 104 of rotator 100. Theapparatus is configured so that this occurs before the blunting memberblunts the needle. The continued rotation of rotator 100 in response tothe further insertion of the sample tube then moves actuator 130 backupwards. At the point of full insertion of the sample tube, the devicereaches the retracted configuration of FIG. 8B, in which tabs 134 b ofactuator 130 hold shuttle 24 (not shown) in the retracted position,leaving the needle assembly in the sharpened configuration. Uponwithdrawal of the sample tube, spring 154 drives the device back to thedeployed configuration of FIG. 8A, and actuator 130 advances shuttle 24forward, blunting the needle. Insertion of yet another collection tubewill bring the device back to the sharpened configuration of FIG. 8E.

[0075] In accordance with another embodiment of the invention, thetransmitter may be dimensioned and configured to engage the samplecollection tube. For example, a transmitter 120′ shown in FIG. 8D has agenerally cylindrical configuration that defines a cylindrical receivingregion C and driving surfaces 124 corresponding to those of transmitter120 (FIG. 6). In addition, however, transmitter 120′ comprises areceiving ferrule 120 b that extends axially from bearing surface 120 ain a direction opposite from driving surfaces 124. Receiving ferrule 120b defines an interior region that is dimensioned and configured toreceive the seal cap on a conventional sample blood collection tube. Inaddition, receiving ferrule 120 b carries a leaf spring 120 e which mayoptionally be formed integrally therewith as shown in the Figure. Leafspring 120 c protrudes into the interior region of receiving ferrule 120b and it is configured so that it will be displaced by a samplecollection tube inserted therein. As suggested in FIG. 8E, a collectiontube such as blood collection tube 56 a, which carries a seal cap 56 b,may be inserted into the cylindrical shell 138 and thus into thereceiving ferrule 120 b of transmitter 120′ therein. As this occurs,seal cap 56 b will displace leaf spring 120 c outwardly. Leaf spring 120c is configured so that such displacement causes it to bear against theinterior of the holder shell, thus increasing the friction betweentransmitter 120′ and the surrounding shell 138. This added frictionhelps keep tube 56 a in place during the filling process despite thebias of spring 154.

[0076] The embodiment of FIG. 9A provides a schematic illustration of alever-based mechanism for the present invention. Mechanism 242 makes useof a ring lever 210, shown in plan view in FIG. 9B and in perspectiveview in FIG. 9C. Ring lever 210 is configured in the shape of a ringhaving a pair of fulcrum studs 212 extending outwardly and coaxiallytherefrom. Studs 212 define the fulcrum of lever ring 210 and dividering 210 into two roughly semicircular arms 212 a and 212 b that extendtherefrom. As sensed in FIG. 9A, arm 212 a extends upward (or forward)and comprises a pintle 218 a for connecting to the actuator 230 in ahinge-like manner that permits pintle 218 a to move radially so thatring lever 210 can pivot. Arm 212 b extends downward (rearward) andcomprises a bearing portion 218 b for engaging the transmitter baffle220 in a manner that allows movement corresponding to that of pintle 218a on actuator frame 230. The central region 216 (FIG. 9B) of ring 210 isconfigured to allow the blunting member and associated shuttle to passtherethrough.

[0077] When ring lever 210 is mounted by studs 212 for rotation abouttheir axis, a force applied to a non-axial point on ring 210, asindicated by the application of force F1 at a point diametricallyopposite from pintle 218 a, will produce a rotation about studs 212. Assensed in FIG. 9C, an upward motion of bearing portion 218 b resultingfrom an upwardly-directed force F1 will produce a contrary, downwardmotion of pintle 218 a, as indicated by arrow F2. Lever ring 210 thusoperates as a lever of the first class (one in which the fulcrum isbetween the applied force and the load).

[0078] In accordance with this aspect of the invention, ring lever 210is mounted inside holder shell 238 with studs 212 rotatably disposed atright angles to the longitudinal axis of the shell. Pintle 218 a isconnected to an actuator frame 230 by engaging a lift arm 230 aconnected thereto. A transmitter baffle 220 is mounted within shell 238for axial sliding motion between a stop member 238 a on shell 238 andframe 230. Transmitter baffle 220 defines a large internal aperture (notshown) to permit the filling needle at the rearward end of the bluntingmember, and the blunting member shuttle 24 to pass therethrough. Aspring 54 is partially compressed between shuttle flanges 32 and baffle220.

[0079] Actuator frame 230 is slidably disposed within shell 238. It willbe apparent that the insertion of a sample collection tube that ispressed against transmitter baffle 220 will apply a force on bearingportion 218 b of ring lever 210 at an end thereof opposite from pintle218 a, corresponding to force F1 (FIG. 9C). Ring lever 210 will rotateabout studs 212 causing pintle 218 a to move in the contrary directionindicated by arrow F2 (FIG. 9C). Since pintle 218 a engages the slidableactuator frame 230, the upward (as sensed in FIG. 9A) movement of baffle220 produces a contrary, downward motion of frame 230.

[0080] Actuator frame 230 is configured similarly to actuator ferrule 50of mechanism 42 (FIG. 3) insofar as it permits the initial installationof needle assembly 30 in shell 238 in the sharp configuration while themechanism remains in the pre-filling configuration of FIG. 9A. However,the internal configuration of actuator frame 230 will cause it torelease detent 28 when it moves rearward (downward as sensed in FIG. 9A)in response to the first insertion of a sample tube into shell 238.Then, the needle is sharp while the device is in the fillingconfiguration. Upon the subsequent removal of the sample collectiontube, spring 54 will push shuttle 24 (and the actuator frame 230 bearingthereon) upward, thus moving the mechanism to the deployed configurationand the needle assembly (not fully shown) to the blunted configuration.The subsequent insertion of another sample tube will move baffle 220upward and the resulting action of ring lever 210 will pull actuatorframe 230 and shuttle 24 resting thereon downward in a directioncontrary to the direction of insertion of the sample collection tube,moving the mechanism to the retracted configuration and the needleassembly to the sharpened configuration.

[0081] In a related lever-type embodiment shown in FIG. 9D, mechanism242′ comprises a transmitter baffle 220′, a ring lever 210′ and anactuator 230′ that are integrally interconnected by hinge straps 218 a′and 218 b′ that are secured thereto. As shown in FIG. 9D, mechanism 242may be considered a single piece. Hinge straps 218 a′, 218 b′ aresufficiently pliable to allow the necessary movement between lever 210′and draw transmitter baffle 220′ and actuator 230′ as lever 210′ pivotsto draw baffle 220′ and actuator 230′ towards each other and then pushthem apart. Strap hinges 218 a′ and 218 b′ may be formed, for example,from a polymeric material. Optionally, transmitter baffle 220′ and/oractuator 230′ may be formed from the same material as the hinge strapconnected thereto and they may be molded together with the hinge strapin a single operation, leaving a distal end of the hinge strap free tobe secured to another structure of mechanism 242′. For example, lever210′ may be formed with hinge straps 218 a′ and 218 b′ extendingtherefrom, and the distal ends of the straps may be secured to baffle220′ and actuator 230′ by any suitable method, e.g., by adhesive, sonicwelding, etc. Alternatively, mechanism 242′ might be formed as a wholein a single molding operation.

[0082] According to yet another embodiment of the invention, a mechanism342 shown in FIG. 10A comprises pliable, resilient straps 310 connectinga transmitting sleeve 320 and an actuator ferrule 350. Straps 310 areconfigured to have a reverse bend about pins 348, and so extend forwardfrom the forward edge of transmitting sleeve 320, around pins 348 toactuator ferrule 350, from which it extends forward as well. In theregion of the reverse bend around pins 348, straps 310 may slidably bearagainst the interior of forward end 36 a of holder 36. FIG. 10A showsthe device in a blunted configuration corresponding to the configurationshown in FIG. 4B. When a collection tube is inserted into holder 36,transmitting sleeve 320 is moved forward in holder 36, pushing straps310 against the forward end 36 a of holder 36. Straps 310 loop aroundpins 348 and push actuator ferrule 350 rearward, unlocking needleassembly 30 and pulling shuttle 24 to a retracted position as shown inFIG. 10B, placing the device in a sharpened configuration. Thus, straps310 constitute a reversing link between the transmitting sleeve 320 andthe actuator ferrule 350, performing an equivalent function to the gearand toothed splines of the embodiment of FIG. 3.

[0083] In each of the foregoing embodiments, the transmitter is movableaxially, i.e., longitudinally, in the shell, and it is not fastened tothe shell. According to other embodiments of this invention, however,the transmitter device may move directly or indirectly to and frorelative to the central axis of the shell, thus moving obliquelyrelative to the motion of a sample collection tube being inserted into,or withdrawn from, the shell. Such radial motion is also obliquerelative to the axial forward and rearward motions of the actuator. Incontrast to previously described embodiments, the transmitter device mayoptionally be fastened to the shell, since no substantial axial movementis required of it. In such embodiments, the transmitter device maycomprise at least one, preferably at least two, resilient arms securedto the interior of the holder. The transmitter device, i.e., one or moretransmitter arms, is configured so that when a collection tube isinserted into the holder, the tube bears against it and presses itsideways towards the shell of the holder. Thus, the transmitter devicemoves obliquely relative to the collection tube. A linkage between thetransmitter device and the actuator, such as a cam and followerengagement between them, converts the oblique (sideways) motion of thetransmitter device into forward or rearward motion of the actuator.Thus, the transmitter device moves obliquely relative to the actuator.As with the previously described embodiments, the motion of the actuator(and of the blunting member, when one is secured thereto) is opposite tothat of the sample collection tube. One example of such an embodiment isshown in the accompanying FIG. 11, in which a blood collection needle455 comprises a holder 436 in accordance with the present invention.Holder 436 comprises a cylindrical shell 438 which has a front end 436 aand a back end 436 b and a mechanism 442 therein, described below. Atfront end 436 a, shell 438 defines a needle hub 410 in which a needlecannula 422 is mounted. Back end 436 b and shell 438 are dimensioned andconfigured to receive a sample collection tube therein.

[0084] In a blunting mechanism 442, the transmitter device comprises aset of resilient transmitting arms 444 a which are mounted in theinterior of shell 438 and which extend forwardly in the interior of theshell. Transmitting arms 444 a also extend towards the central axis ofthe shell so that when a sample collection tube is inserted in the backend of holder 436, it bears against transmitting arms 444 a.Transmitting arms 444 a, being flexible and resilient, are displacedfrom the central region of shell 438 towards the wall of the shell asthe sample collection tube moves forward in holder 436, and transmittingarms 444 a move inwardly as the sample collection tube is withdrawn,i.e., the arms move obliquely (i.e., radially) relative to the generallyaxial motion of the sample collection tube. In the illustratedembodiment, transmitting arms 444 a are fastened to the shell near theback end of the shell and extend forwardly therein (in otherembodiments, they might extend rearwardly from the front). Each oftransmitting arms 444 a carries a wedge 446 a which points outwardly,towards shell 438, and each wedge has a cam surface S.

[0085] Blunting mechanism 442 also comprises a ferrule-shaped actuator450 disposed within shell 438. Actuator 450 is dimensioned andconfigured to receive therein the transmitting arms 444 a. Actuator 450comprises a cannula hub 451 which engages a second cannula 426 whichextends forwardly therefrom and is disposed concentrically within needlecannula 422. The forward-extending portion of cannula 426 terminateswith a blunt end and constitutes the blunting member 426 a of thedevice. Cannula 426 also extends rearward, terminating at a sharp endfor puncturing the seal on a sample collection tube and for providing aconduit for fluid flow between the sample collection tube in holder 436and needle cannula 422. The sharp end of cannula 426 is covered with aself-resealing boot 427 which blocks fluid flow from the tip end ofcannula 426 until the boot is displaced by a collection tube. The bootre-seals cannula 426 when the collection tube is removed, as is known inthe art. Cannula 426 is secured to actuator 450 so that it moves withactuator 450. A spiral spring 454 is positioned within shell 438 to urgeactuator 450 forward and serves as a biasing member in this embodiment.Other biasing members, e.g., other types of springs, an elastic band,etc., may be used as a biasing means in place of spring 454. Since theannular portion of actuator 450 extends rearward from hub 451, it isconfigured to seat the end of a sample collection tube and permit theblunting cannula to perforate the seal on the collection tube.

[0086] Needle cannula 422, second cannula 426, actuator 450, transmitterarms 444 a and shell 438 are dimensioned and configured so that whenactuator 450 is in its forward-most position within shell 438, bluntingmember 426 a extends beyond the sharp tip of needle cannula 422, thusblunting the device, Le., the device is in a blunted configuration. Theyare further configured so that when actuator 450 is moved rearward underthe operation of mechanism 442, the blunt end of blunting member 426 ais withdrawn into needle cannula 426, thus exposing the sharp tip of theneedle and placing the device in a sharpened configuration, as follows.Actuator 450 is equipped with wedge apertures 452. Arms 444 a and wedges446 a are configured so that when a sample tube is inserted into holder436, the tube bears against arms 444 a, pushing them outward so thatsurfaces S engage the rearward interior edge of wedge apertures 452. Asthe sample collection tube moves arms 444 a still farther apart from oneanother, wedges 446 a are driven farther outward and actuator 450 ridesalong surfaces S and is thus moved backward in the device. Thus,surfaces S serve as cam surfaces and actuator 450 serves as a camfollower. In this embodiment, arms 444 a are configured so that thesample collection tube contacts arms 444 a at a point between theirconnection to shell 438 and their linkage to actuator 450. The arms 444a flex about their points of attachment to shell 438, which serve astheir fulcrums. It may be noted that the arms 444 a move in response toa force applied by the sample tube between the fulcrum and the load(actuator 450), so arms 444 a act as levers of the third class. Ifnecessary, shell 438 may comprise shell apertures 438 a to accommodatethe protrusion of wedges 446 a entirely through wedge apertures 452.When actuator 450 begins in its forwardmost position (the bluntingposition) and is then moved rearward by arms 444 a and wedges 446 a,blunting member 426 a is withdrawn from its blunting position towards aposition within needle cannula 422 (the sharpened position), thussharpening the device. Arms 444 a may be configured to cause actuator450 to fully withdraw blunting member 426 a into needle cannula 422,which is typically achieved with a travel of about 0.2 inch. Uponwithdrawal of the sample collection tube from the holder, the resilienceof arms 444 a causes them to return towards the central region in shell438, and surfaces S then permit actuator 450 to advance under theimpetus of spring 454. In an alternative embodiment, a positive motioncam may be established between arms 444 a and actuator 450 and thespring-like arms 444 a may comprise the biasing means due to theirresiliency to advance the actuator 450 when arms 444 a resume theirinwardly-disposed configuration.

[0087] In another embodiment of the invention, the full withdrawal ofblunting member 426 a is accomplished in a staged manner by a pluralityof sets of wedges. In such an embodiment, a holder 436, shown in FIGS.12A, 12B and 12C, comprises a transmitter device comprising a first setof arms 444 b with wedges 446 b which may be configured to withdraw theactuator 450′ and a blunting member (not shown) only part way, e.g., 0.1inch. The transmitter device further comprises a second set of arms 444c and wedges 446 c, and an actuator 450′ and shell 438′ which compriseapertures to accommodate both sets of wedges in a manner similar to thatshown in FIG. 11. In such an embodiment, however, the second set ofwedges 446 c may be situated at a different point on the front-to-backlength of shell 438 than the first set of wedges 446 b. Thus, themechanical action of the two sets of wedges is staggered. Each set mayseparately accomplish a part, e.g., approximately half, of thewithdrawal motion to move blunting member 426 a from its extended,blunting position to its withdrawn, sharpened position, over different(although possibly overlapping) time intervals from the other set ofwedges as the sample collection tube is inserted into the holder. Thus,arms 444 b in shell 438′ are configured for the first contact with asample collection tube and wedges 446 b thereon are configured to effecta first portion of the rearward motion of actuator 450′ by engagingapertures 438 b. Arms 444 c are configured for contact with the samplecollection tube after arms 444 b, and wedges 446 c thereon areconfigured to effect the completion of the rearward motion of actuator450′ by engaging apertures 438 c to sharpen the device. FIG. 12Cprovides an end view in which both sets of arms 444 b and 444 c arevisible.

[0088] To provide a blood collection device of the present invention inan initially sharpened state prior to the first insertion of a samplecollection tube, the transmitter arms can be extended beyond the wedgesto include locking detents to retain the actuator in the withdrawnposition prior to the first insertion of a sample collection tube intothe device. For example, holder 436″ of FIG. 13A comprises arms 444 dwhich carry wedges 446 d for engaging wedge apertures 452 e. Arms 444 dcarry locking extensions 444 e which terminate in locking detents 446 b.Actuator 450″ is provided with corresponding locking apertures 450 fconfigured so that when actuator 450″ is in an initial, rearwardposition, locking tabs 446 b engage the front surface of actuator 450″via locking apertures 450 f, as seen in FIG. 13B. Thus, the device maybe disposed in an initial sharpened configuration even without a samplecollection tube therein. Locking apertures 450 f are dimensioned topermit arms 444 d to move outwardly (i.e., radially relative to thecentral axis of shell 438, with which cannula 426 is aligned) and thusdisengage tabs 446 b from the actuator. Arms 444 a are configured sothat upon the initial insertion of a sample collection tube into shell438, the arms are moved apart sufficiently to disengage locking tabs 446b from actuator 450″ as indicated by arrows 453. Actuator 450″ is thenfree to move forward under the pressure of a spring (not shown) likespring 454 (FIG. 11). As the sample tube is inserted further, however,the mechanism in the holder causes actuator 450″ to move rearward again.The sample tube spreads arms 444 d so that they pass through apertures450 f as actuator 450″ moves rearward to a retracted position to sharpenthe device. When the sample tube is withdrawn, actuator 450″ movesforward, but the sample tube prevents tabs 446 b from engaging thenotches in apertures 450 f Instead, actuator 450″ moves forward beyondthe notches and beyond the ends of extensions 444 e. Finally, arms 444can move towards the center of the device and actuator 450″ is fullyadvanced so that the blunting member blunts the needle cannula. The endsof arms 444 can then move toward the center of the shell into positionto bear against the central portion of the actuator, as shown in FIG.13C, and prevent actuator 450″ from moving rearward, thus locking thedevice in the blunted configuration. When another sample collection tubeis inserted into the device, arm extensions 444 e will be driven outwardso that they align with apertures 450 f and they will thus permit themechanism to move the blunting member rearward to sharpen the device. Itwill therefore be understood that tabs 446 b only hold actuator 450″ inthe forward position in an initial configuration prior to the firstinsertion of a sample collection tube into the needle.

[0089] In use, a blood collection needle comprising holder 436″ isinitially provided in an initial sharpened configuration in whichactuator 450″ and a second (blunting) cannula (not shown) are withdrawnto the sharpened position and actuator 450″ is engaged by locking tabs446 b (FIGS. 13A and 13B). In this initial sharpened configuration, theuser can effect venipuncture with the needle cannula (not shown) in hub410 and with the cannula boot (not shown) preventing fluid flow. Then,upon the initial insertion of a sample collection tube into holder 436″,arms 444 d move apart sufficiently to disengage locking tabs 446 b fromactuator 450″ (as suggested by arrows 453). A spring (not shown) thenurges actuator 450″ forward, temporarily blunting the device. Uponfurther insertion of the sample collection tube, the cam surfaces S ofwedges 446 d engage apertures 452 e, thus moving actuator 450″ and theblunting member secured thereto rearward so that the needle is sharpenedas the sample collection tube is fully inserted into the device. At thesame time, the boot 427 is pushed past the sharp end of cannula 426 asthe cannula pierces the seal on the collection tube to allow fluid flowinto the tube. Actuator 450″ is not retained in this position by lockingtabs 446 b because arms 444 d are held apart by the sample tube and socannot engage locking apertures 450 Therefore, upon removal of thesample collection tube, actuator 450″ moves forward again to theblunting position as wedges 446 a withdraw from apertures 450 f By thetime the sample collection tube is withdrawn, arms 444 d have beenwithdrawn from apertures 450 f and they are behind the central portionof actuator 450″, locking the device in the blunted configuration untilanother sample collection tube is inserted into the device.

[0090] Still another embodiment in accordance with the present inventionis shown in FIGS. 14A through 15. In this embodiment, the transmitterdevice comprises two transmitter arms, each attached to one side of theinterior of the holder and extending towards the other side. Thetransmitter arms terminate in lugs which ride on cam surfaces formed onthe actuator. When a collection tube is inserted into the holder, thetraversing sections of the transmitter arms are moved by the collectiontube so that the lugs bear on the cam surfaces, thus moving theactuator. In particular, FIG. 14A shows a holder 536 for a bloodcollection needle comprising a shell 538 which has a generallycylindrical configuration with a front end 538 a in which is formed aneedle aperture 540 within which the needle may be mounted. Optionally,needle aperture 540 may be configured in the same manner as the mountingportion 14 a of needle hub 10 (FIG. 1A), which has funnel-like insertionregions to facilitate the insertion of the needle therein and of theblunting member into the needle cannula. At the back end 538 b, shell538 comprises a finger flange 538 c for the convenience of the user.Within shell 538, mechanism 542 effects rearward motion of a bluntingmember (to sharpen the device) in response to the insertion of a samplecollection tube in the device. Mechanism 542 comprises transmitter arms546 a, 546 b, actuator 550 and spring 554. Transmitter arm 546 b isattached to shell 538 at the back end thereof and extends in a forwarddirection and generally traverses the central, interior portion of theshell (from left to right as sensed in FIG. 14A) to terminate at lug 548b. Transmitter arm 546 a is configured similarly to arm 546 b, but it isattached on the shell at a point generally opposite from where arm 546 bis attached and it traverses the central portion of shell 538 in theopposite direction, as suggested in FIG. 14A. Actuator 550 carries amounting lug in which a mounting aperture 524 is formed for receiving ablunting member. Actuator 550 also carries wedges 550 a, 550 b, each ofwhich forms a cam surface 552 a, 552 b, respectively. Lug 548 a ispositioned to bear against cam surface 552 a and lug 548 b is positionedto bear against cam surface 552 b. In the configuration shown in FIGS.14A and 14B, actuator 550 is in the forwardmost position under the biasof spring 554, with lugs 548 a and 548 b at their lowest points on theirrespective cam surfaces 552 a, 552 b. In the view of FIG. 14B, it can beunderstood that while arms 546 a and 546 b appear to cross each other atabout the center of shell 538, they also extend in planes that aregenerally parallel to one another. In the view of FIG. 14B, cam surface552 a is sloping downward into the foreground of the FIG. but camsurface 552 b faces away from the viewer and is not visible in thatFigure. By comparing the views of FIGS. 14B and 14C, it will beunderstood that actuator 550 defines a pair of generally parallel slots550 c and 550 d which straddle aperture 524 and that wedges 550 a and550 b are formed alongside the slots. Slots 550 c and 550 d admit arms546 a and 546 b therethrough to allow lugs 548 a to rest on cam surface552 a and lug 548 b to rest on cam surface 552 b. The comparison ofthese FIGS. will also make clear that in the view of FIGS. 14B and 14C,cam surface 552 b is inclined away from the viewer, and so is notvisible in these Figures.

[0091] Referring again to FIG. 14a, it can be understood that when asample collection tube is inserted into holder 536, it will bear againstthe mid-portions of transmitter arms 546 a and 546 b, between where arms546 a and 546 b are attached to shell 538 and where they engage actuator550, and bend them towards the sides of shell 538 to which they areattached. Lugs 548 a and 548 b will then bear against cam surfaces 552 aand 552 b, thus moving actuator 550 rear-ward (downward as sensed inFIGS. 14A and 14B) against the bias of spring 554. The result of such anarrangement is shown in FIG. 15, in which the insertion of samplecollection tube 56 a has substantially straightened transmitter arms 546a and 546 b so that they no longer traverse the central portion of theshell 538. Lugs 548 a and 548 b rest at the top of cam surfaces 552 aand 552 b, respectively and have driven actuator 550 rearward, thuscompressing spring 554. The blunting member 26 a carried on actuator 550is moved rearward in the device to the blunting configuration, leavingthe tip of needle 26 exposed. Withdrawal of collection tube 56 a willpermit arms 546 a and 546 b to return to their crosswise configuration,thus allowing spring 554 to move actuator 550 forward, advancingblunting member 26 a so that it protrudes from needle 22, thus bluntingthe device.

[0092] Optionally, any of the embodiments of FIGS. 11-15 may easily beconfigured to receive a removable needle and blunting member assembly ofthe kind shown in U.S. Pat. No. 5,951,520, the disclosure of which ishereby incorporated herein by reference.

[0093] While the invention has been described in detail with referenceto particular embodiments thereof, it will be apparent that upon areading and understanding of the foregoing, numerous alterations to thedescribed embodiments will occur to those skilled in the art and it isintended to include such alterations within the scope of the appendedclaims.

What is claimed is:
 1. A bluntable blood collection needle comprising: aneedle cannula comprising a forward puncture tip, a rearward end, and aneedle passageway therethrough; a blunting member comprising a forwardblunt tip and a rearward tip, wherein the blunting member is receivedtelescopically within the needle passageway with the forward tipspointed in the same direction, and the blunting member is movablebetween an insertion configuration, in which the puncture tip of theneedle cannula is exposed, and a blunted configuration, in which theblunt tip of the blunting member extends beyond the puncture tip of theneedle cannula; a needle hub comprising a forward end, a rearward end, ahub passageway extending therethrough forming a shuttle portion and awall, and a forward locking notch and a rearward locking notch throughthe wall, wherein the needle cannula extends from the forward end of theneedle hub; a blunting member shuttle comprising a forward end, arearward end, an axial passageway, a detent mounted on a resilient arm,and a shuttle flange, wherein the blunting member shuttle is slidablyreceived within the shuttle portion of the hub passageway, the bluntingmember is mounted on the blunting member shuttle, the detent isdimensioned and configured to engage and to protrude through, and ismovable between the forward locking notch and the rearward lockingnotch, and comprises an obliquely disposed protruding surface, and theblunting member is in the insertion configuration when the detent isengaged in the rearward locking notch, and in the blunted configurationwhen the detent is engaged in the forward locking notch.
 2. The bloodcollection needle of claim 1, wherein the blunting member extendsrearwardly from the blunting member shuttle and the proximal tip is asharp end.
 3. The blood collection needle of claim 1, wherein therearward end of the blunting member shuttle further comprises a bootbarb and a self-sealing boot mounted thereon.
 4. The blood collectionneedle of claim 1, wherein the forward end of the hub passageway definesa proximal insertion region that converges rearwardly from the forwardend of the needle hub, thereby facilitating the insertion of therearward end of the needle cannula into the hub passageway.
 5. The bloodcollection needle of claim 1, wherein forward end of the shuttle portionof the hub passageway defines a second insertion region that convergesforwardly toward the forward end of the needle hub, thereby facilitatingthe insertion of the blunting member into the passageway of the needlecannula.
 6. The blood collection needle of claim 5, wherein the secondinsertion region converges to a diameter larger than the diameter of theblunting member and smaller than the diameter of the needle passageway,and is aligned therewith, thereby forming a stop for the rearward end ofthe needle cannula.
 7. The blood collection needle of claim 1, whereinwall of the needle hub further comprises a channel extending between theforward notch and the rearward notch dimensioned and configured topermit the detent to slide therein when the blunting member is movedbetween the insertion configuration and the blunted configuration. 8.The blood collection needle of claim 1, wherein the needle hub furthercomprises a locking flange and a locking spline.
 9. The blood collectionneedle of claim 1, wherein the shuttle flange is dimensioned andconfigured to engage a means for moving the blunting member between theinsertion configuration and the blunted configuration.